KPMG Pharma Bulletin Issue #6, 2017 (June)

KPMG Pharma Bulletin Issue #6, 2017 (June)

Victoria Samsonova

Director, Head of Healthcare & Pharmaceuticals

KPMG in the CIS


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Parliamentaries rejected the bill amending pharmaceuticals procurement procedure

The State Duma rejected the Bill # 1180507-6 "On Amendments to Certain Legislative Acts of the Russian Federation", which was proposing amendments to procedures of pharmaceuticals procurement.

Particularly, the bill suggested:
- removing the requirement to specify a pharmaceutical’s international non-proprietary name in the procurement documentation;
- empowering physicians to make decisions on purchases of pharmaceuticals in a simplified way, by submitting purchase orders or by purchasing from a sole supplier approved by the medical commission resolution.


Ministry of Healthcare suggests amendments to the rules of controlled pharmaceuticals circulation

The Ministry of Healthcare of the Russian Federation has developed amendments to the Orders # 30н, # 183н and # 378н governing the circulation of pharmaceuticals subject to strict record keeping.

The changes are aimed at clearing the existing inconsistencies in interpreting the legal provisions on circulation of the controlled pharmaceuticals which contain narcotic, psychotropic substances and their precursors, as well as potent and toxic ingredients.

It is proposed to update the Order # 30н by allowing preventive inclusion into the List of controlled pharmaceuticals of drugs registered in Russia for the first time, if the registration is applied for by the holder (the owner) of the registration certificate, and provided that there are no registered pharmaceuticals with the same INN circulated in the Russian market.

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Rules approved for biomedical examination of biomedical cellular products

On June 08, 2017, the Russian Ministry of Justice registered the Order of Ministry of Healthcare # 30н dd. 31.01.2017 "On Approval of Rules for Carrying out Biomedical Expert Examination of Biomedical Cellular Products and Templates of Resolutions of the Expert Commission of Federal State Budgetary Institutions for Conducting Biomedical Expert Examination of Biomedical Cellular Products".

The document enacts:
─ Rules for carrying out biomedical expert examination of biomedical cellular products (BMCP);
─ Template of the resolution of the expert commission of a federal state budgetary institution upon conducting the biomedical expertise following the BMCP quality assessment;
─ Template of the resolution of the expert commission upon the results of BMCP efficacy assessment;
─ Template of the resolution of the expert commission upon the results of a BMCP risk-benefit assessment.


Rules of forming special lists of pharmaceuticals amended

The Government has amended the rules of forming the special lists of pharmaceuticals for medical use and of the minimum assortment of pharmaceuticals. The corresponding Decree # 700 dd. 12.06.2017 "On Amendments to Resolution of the Government of the Russian Federation dd. 28.08.2014 # 871" has been signed by the Prime Minister.

Particularly, according to the amended rules, inclusion of any pharmaceutical into the list of high-priced pharmaceuticals should not result in an increase of the funds reserved in the federal budget for the corresponding financial year. Also, the provision on pharmaceuticals’ production (localization) in Russia was updated by adding information on the production stages (secondary packaging, primary packaging, production of active pharmaceutical ingredient, etc.).

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Ministry of Healthcare to improve the safety profiles of registered generic drugs

The Ministry of Healthcare has placed for public discussions the bill "On Amendments to the Federal Law "On Pharmaceuticals Circulation".

The document was developed in order to improve the safety profile of the registered generic pharmaceuticals associated with insufficient clinical efficacy. The bill also clarifies the "reference pharmaceutical" definition, particularly using the reference pharmaceutical for assessment of generics’ bioequivalence or therapeutically equivalence, quality, efficacy and safety shall be performed within the single INN.

The draft law is also aimed at enabling the possibility to reconsider pharmaceuticals’ interchangeability, in cases of changes to the documents contained in the registration dossier for the registered pharmaceutical for medical use, if such changes affect the drug’s interchangeability.


Moscow pharmacies operating in healthcare facilities may be exempt from the trade duty

The draft law of the City of Moscow "On Amendments to Article 3 of the Law of the city of Moscow dd. 17.12.2014 # 62 "On Trade Duty " has been submitted for the consideration to the Moscow Duma.

The bill proposes the trade duty exemption for pharmacies trading in the premises of state budgetary and public medical institutions, provided that a pharmacy occupies not more than 50 square meters.

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Fee increase for GMP audit is proposed

The Ministry of Industry and Trade has placed for public discussions the draft departmental order "On Amendments to the Order of Ministry for Industry and Trade of the Russian Federation # 9 dd. 11.01.2016 "On Approval of the Methodology for Determining the Service Fee for the GMP Compliance Inspection of Pharmaceuticals Manufacturers Producing Pharmaceuticals outside the Russian Federation for the Purposes of Issuing GMP Compliance Resolutions, and the Upper Limit of this Service Fee".

The document provides a formula for calculation of the service fee for the GMP compliance audit and the upper fee limit of RUB 4.3 MM net of VAT (or RUB 5.1 MM VAT-inclusive).

Up to now, the fee has been limited by RUB 1.7 MM excluding travel expenses, or RUB 2.9 MM including those.

Procurement rules simplified for state-owned pharmacies

The President of Russia signed the Federal Law "On Amendments to Articles 1 and 8 of the Federal Law # 223-FZ "On Procurement of Goods, Works, Services by Certain Legal Entities" and Articles 15 and 112 of the Federal Law # 44-FZ "On the Contract System for Procurement of Goods, Works, Services for State and Municipal Needs".

The Law enables pharmacies which are set-up in the form of state or municipal unitary enterprises to perform procurements without applying for funding from the budget.

Such pharmacies are now entitled to initiate procurements in accordance with the Federal Law # 223-FZ, by means of publishing the procurement regulation and the procurement plan in the unified database at

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